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What is ISO 9000?
The term
ISO 9000
refers
to a set of quality management standards. ISO 9000 currently includes three quality standards: ISO 9000:2005, ISO 9001:2000, and
ISO 9004:2000. ISO 9001:2000 presents requirements, while ISO
9000:2005 and ISO 9004:2000 present guidelines. All of these are
process standards
(not product standards).
ISO first published its quality standards in 1987,
revised them in 1994, and then republished an updated version in 2000. These
new standards are referred to as the "ISO 9000 2000 Standards".
The
ISO 9000 Standards apply to all kinds of organizations in
all kinds of areas. Some of these areas include
manufacturing, processing, servicing, printing, forestry,
electronics, steel, computing, legal services, financial
services, accounting, trucking, banking, retailing,
drilling, recycling, aerospace, construction,
exploration, textiles, pharmaceuticals, oil and gas, pulp
and paper, petrochemicals, publishing,
shipping,
energy,
telecommunications, plastics, metals, research,
health
care, hospitality, utilities, pest control, aviation, machine tools,
food processing, agriculture, government, education,
recreation, fabrication, sanitation, software
development, consumer products, transportation,
design, instrumentation, tourism,
communications, biotechnology, chemicals, engineering, farming, entertainment, horticulture, consulting, insurance, and so on.
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How does ISO 9001
Work?
Here's how it works. You decide that you need to develop a
quality management system that meets the new
quality
standard. That's
your mission. You
choose to follow this path because you feel the need to
control or improve the quality of your
products and
services, to reduce the
costs associated with poor
quality, or to become more competitive. Or, you choose
this path simply because your customers expect you to do
so or because a governmental body has made it mandatory. You then develop a quality
management system
that meets the
requirements specified by ISO 9001:2000 (ISO 9002 and 9003 have been dropped).
In the course of doing so, you may also wish to consult the ISO 9000:2005
and ISO 9004:2000 guidelines. However, please remember that your quality management system must meet ISO's
requirements,
not its guidelines.
But how do you develop such a
quality
management
system? There are at least two approaches. You can do either a
Gap Analysis or follow a detailed System Development
Plan.
If you've already got a quality management system and you're happy with the way it operates, then we suggest that you use a Gap Analysis to upgrade to the new
ISO 9001 2000 standard. A
Gap Analysis will tell you
exactly what you need to do to
meet the ISO 9001 2000
Quality Management Standard. It will help
you identify the gaps that exist between the
new ISO
Standard and
your organization's processes. Once you know where the gaps are, you
can take steps to fill your gaps. By following this incremental approach, you will not only comply with the new ISO 9001 Standard, but you will
also improve the overall performance of your organization's processes.
However, if you don't have a quality management
system
or you're not happy with the one you've got, then we suggest that you use our
ISO 9001 2000 Process Oriented Quality Management System Development Plan to develop your quality
management system. If
you follow the detailed steps that make up our System Development Plan, you'll
end up with a quality management
system that will meet your needs and ISO's
requirements.
Once
your quality management system has been fully developed and
implemented, you carry out an Internal Audit
to ensure that you've met every single ISO 9001 2000
requirement.
When you're
ready, you ask a Registrar to audit the effectiveness of your
quality
management system. If your
auditors like what they see, they will certify that your
quality system has met ISO's requirements. They
will then issue an official certificate to you and they
will record your achievement in their registry.
You can
then announce to the world that the quality of your
products and services is managed, controlled, and assured
by a registered ISO 9001 Quality Management System!
However,
you don't have to be registered. ISO does not require
formal registration (certification). You can be in
compliance without being registered by an accredited
auditor. But, your customers are more likely to believe
that you have an effective quality management system if an independent external auditor says so.
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Why
is ISO 9001 Important?
ISO 9001 is important because
of its orientation. While the content itself
is useful and
important, the content alone does not account for its widespread appeal.
ISO 9001 is important because
of its international
orientation.
Currently, ISO 9001 is supported by
national standards
bodies from
more than 120 countries. This makes it the logical choice for any organization that does business internationally or that serves
customers who demand an international standard of quality.
ISO 9001 is also important because
of its systemic orientation.
We think this is crucial. Many people in this field wrongly emphasize
motivational and attitudinal factors. The assumption is that quality can only be created if workers are motivated and have the right
attitude. This is fine, but it doesn't go far enough. Unless you institutionalize
the right
attitude by
supporting it with the right
policies, procedures, records, technologies, resources, and structures,
you will never achieve the standards of quality that other
organizations seem to be able to achieve. Unless you establish a
quality attitude by creating a quality system, you will never achieve a world-class standard of quality.
Simply put,
if you want to have a quality
attitude you must have a
quality system. This is what ISO recognizes, and this is
why ISO 9000 is important.
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